Vetmedin 1.25 mg chewable tablets for dogs

Ireland - English - HPRA (Health Products Regulatory Authority)

Active ingredient:
Pimobendan
Available from:
Boehringer Ingelheim Ltd
ATC code:
QC01CE90
INN (International Name):
Pimobendan
Dosage:
1.25 mg/tablet
Pharmaceutical form:
Chewable tablet
Prescription type:
POM: Prescription Only Medicine as defined in relevant national legislation
Therapeutic group:
Dogs
Therapeutic area:
pimobendan
Therapeutic indications:
Cardiovascular
Authorization status:
Authorised
Authorization number:
VPA10007/050/001
Authorization date:
2012-11-05

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Health Products Regulatory Authority

14 September 2017

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1 NAME OF THE VETERINARY MEDICINAL PRODUCT

Vetmedin 1.25 mg chewable tablets for dogs

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

One chewable tablet contains:

Active substance:

Pimobendan 1.25 mg

Excipients:

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Chewable tablet.

Oblong, scored, mottled brown tablets with fine white spots, embossed with

Boehringer Ingelheim logo and P01.

The tablet can be divided into equal parts.

4 CLINICAL PARTICULARS

4.1 Target Species

4.2 Indications for use, specifying the target species

For the treatment of canine congestive heart failure originating from dilated

cardiomyopathy or valvular insufficiency (mitral and/or tricuspid valve regurgitation).

(See also section 4.9).

For the treatment of dilated cardiomyopathy in the preclinical stage (asymptomatic

with an increase in left ventricular end-systolic and end-diastolic diameter) in

Doberman Pinschers following echocardiographic diagnosis of cardiac disease (see

sections 4.4 and 4.5).

For the treatment of dogs with myxomatous mitral valve disease (MMVD) in the

preclinical stage (asymptomatic with a systolic mitral murmur and evidence of

increased heart size) to delay the onset of clinical symptoms of heart failure (see

sections 4.4 and 4.5).

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4.3 Contraindications

Do not use pimobendan in hypertrophic cardiomyopathies or in diseases in which an

improvement in cardiac output cannot be achieved for functional or anatomical

reasons (e.g. aortic stenosis).

Since pimobendan is metabolised mainly via the liver, it should not be used in dogs

with severe impairment of liver function (see also 4.7).

4.4 Special warnings for each target species

The product has not been tested in cases of asymptomatic DCM in Dobermans with

atrial fibrillation or sustained ventricular tachycardia.

The product has not been tested in cases of asymptomatic myxomatous mitral valve

disease in dogs with significant supraventricular and/or ventricular tachyarrhythmia.

4.5 Special precautions for use

Special precautions for use in animals

The blood glucose should be tested regularly during treatment in dogs with existing

diabetes mellitus.

For use in the preclinical stage of dilated cardiomyopathy (asymptomatic with an

increase in left ventricular end-systolic and end-diastolic diameter), a diagnosis

should be made by means of a comprehensive cardiac examination (incl.

echocardiographic examination and possibly Holter monitoring).

For use in the preclinical stage of myxomatous mitral valve disease (stage B2,

according to ACVIM consensus: asymptomatic with mitral murmur ≥3/6 and

cardiomegaly due to myxomatous mitral valve disease), a diagnosis should be made

by means of a comprehensive physical and cardiac examination which should include

echocardiography or radiography where appropriate. (See also section 5.1).

Monitoring of cardiac function and morphology is recommended in animals treated

with pimobendan.

(See also section 4.6).

The chewable tablets are flavoured. In order to avoid any accidental ingestion, store

tablets out of reach of the animals.

Special precautions to be taken by the person administering the veterinary medicinal

product to animals

In case of accidental ingestion, seek medical advice immediately and show the

package leaflet or the label to the physician.

Wash hands after use.

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Advice to doctors: accidental ingestion, especially by a child, may lead to the

occurrence of tachycardia, orthostatic hypotension, flushing of the face and

headaches.

Close bottle tightly with cap directly after removal of the required number of tablets.

4.6 Adverse reactions (frequency and seriousness)

In rare cases a slight positively chronotropic effect (rise in heart rate) and vomiting

can occur. However, these effects are dose-dependent and can be avoided by

reducing the dose.

In rare cases transient diarrhoea, anorexia or lethargy have been observed.

Although a relationship with pimobendan has not been clearly established, in very

rare cases, signs of effects on primary haemostasis (petechiae on mucous

membranes, subcutaneous haemorrhages) may be observed during treatment. These

signs disappear when the treatment is withdrawn. In rare cases, an increase in mitral

valve regurgitation has been observed during chronic pimobendan treatment in dogs

with mitral valve disease.

The frequency of adverse reactions is defined using the following convention:

- very common (more than 1 in 10 animals treated displaying adverse reactions)

- common (more than 1 but less than 10 animals in 100 animals treated)

- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

- rare (more than 1 but less than 10 animals in 10,000 animals treated)

- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

4.7 Use during pregnancy, lactation or lay

Laboratory studies in rats and rabbits have not produced any evidence of teratogenic

or foetotoxic effects. However, these studies have shown evidence of maternotoxic

and embryotoxic effects at high doses, and have also shown that pimobendan is

excreted into milk. The safety of the product has not been assessed in pregnant or

nursing bitches. Use only according to the benefit/risk assessment by the responsible

veterinarian.

4.8 Interaction with other medicinal products and other forms of interaction

In pharmacological studies no interaction between the cardiac glycoside

strophanthin and pimobendan was observed. The pimobendan-induced increase in

cardiac contractility is attenuated by the calcium antagonists verapamil and diltiazem

and by the β-antagonist propranolol.

4.9 Amounts to be administered and administration route

Do not exceed the recommended dosage.

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Determine the bodyweight accurately before treatment to ensure correct dosage.

The dose should be orally administered and within the dose range of 0.2 mg to 0.6

mg pimobendan/kg bodyweight, divided into two daily doses. The preferable daily

dose is 0.5 mg/kg bodyweight, divided into two daily doses (0.25 mg/kg bodyweight

each). Each dose should be given approximately 1 hour before feeding.

This corresponds to:

One 1.25 mg chewable tablet in the morning and one 1.25 mg chewable tablet in the

evening for a body weight of 5 kg.

Chewable tablets can be halved at the score line provided, for dosage accuracy,

according to the bodyweight.

The product may be combined with a diuretic, e.g. furosemide.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

In the case of overdose, a positive chronotropic effect, vomiting, apathy, ataxia, heart

murmurs or hypotension may occur. In this situation, the dosage should be reduced

and appropriate symptomatic treatment should be initiated.

In prolonged exposure (6 months) of healthy beagle dogs at 3 and 5 times the

recommended dose, mitral valve thickening and left ventricular hypertrophy were

observed in some dogs. These changes are of pharmacodynamic origin.

4.11 Withdrawal period(s)

Not applicable.

5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group: Cardiac stimulants excl. cardiac glycosides,

phosphodiesterase inhibitors

ATC vet code: QC01CE90

5.1 Pharmacodynamic properties

When used in cases of symptomatic valvular insufficiency in conjunction with

furosemide the product has been shown to improve the quality of life and extend life

expectancy in treated dogs.

When used in a limited number of cases of symptomatic dilated cardiomyopathy in

conjunction with furosemide, enalapril and digoxin, the product has been shown to

improve the quality of life and to extend life expectancy in treated dogs.

In a randomized and placebo controlled study in 363 dogs with preclinical

myxomatous mitral valve disease, all dogs met the following inclusion criteria: age ≥

6 years, bodyweight ≥ 4.1 and ≤ 15 kg, characteristic systolic heart murmur of

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moderate to high intensity (≥ grade 3/6) with maximal intensity over the mitral area;

echocardiographic evidence of advanced myxomatous mitral valve disease (MMVD)

defined as characteristic valvular lesions of the mitral valve apparatus,

echocardiographic evidence of left atrial and left ventricular dilatation and

radiographic evidence of cardiomegaly (vertebral heart sum (VHS) > 10.5. The

median time to onset of clinical signs of heart failure or cardiac death/euthanasia was

extended in these dogs by approximately 15 months. Additionally, there was a

reduction in the heart size of dogs treated with pimobendan in the preclinical stage

of myxomatous mitral valve disease. Furthermore, overall survival time was

prolonged by approximately 170 days in all dogs receiving pimobendan independent

of their cause of death (cardiac death/ euthanasia and non-cardiac death/euthanasia).

Cardiac related death or euthanasia occurred in 15 dogs in the pimobendan group

and 12 dogs in the placebo group prior to the onset of CHF. Dogs in the

pimobendan group spent a longer time in the study (347.4 patient years) than those

in the placebo group (267.7 patient years) resulting in a lower rate of occurrence.

In a randomized and placebo controlled study including Doberman Pinschers with

preclinical dilated cardiomyopathy (asymptomatic with an increase in left ventricular

end-systolic and end-diastolic diameter following echocardiographic diagnosis), the

time to onset of congestive heart failure or sudden death was extended and survival

time was prolonged among dogs administered pimobendan. Additionally, there was

a reduction in the heart size of dogs treated with pimobendan in the preclinical stage

of dilated cardiomyopathy. Efficacy evaluation is based on data from 19 (of 39) and

25 (of 37) dogs that reached the primary efficacy endpoint in the pimobendan and

the placebo group, respectively.

Pimobendan, a benzimadazole-pyridazinone derivative has a positive inotropic

action and possesses pronounced vasodilator properties.

The positive inotropic effect of pimobendan is mediated by two mechanisms of

action: increase in calcium sensitivity of cardiac myofilaments and inhibition of

phosphodiesterase III. Thus the positive inotropism is triggered neither by an action

similar to that of the cardiac glycosides nor sympathomimetics.

The vasodilator effect arises from inhibition of phosphodiesterase III.

5.2 Pharmacokinetic properties

Absorption:

After oral administration of the product the absolute bioavailability is 60 ‑ 63 %.

Since simultaneous or previous food intake reduces the bioavailability, pimobendan

should be administered about 1 hour before feeding.

Distribution:

The volume of distribution is 2.6 l/kg, indicating that pimobendan is distributed

readily into the tissues. The mean plasma protein binding is 93 %.

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Metabolism:

The compound is demethylated by oxidation to the major active metabolite

(UD-CG212). Further metabolic steps are phase II conjugates of UD-CG212, such as

glucuronides and sulphates.

Elimination:

The plasma elimination half-life of pimobendan is 0.4 ± 0.1 hours, which corresponds

to the high clearance of 90 ± 19 ml/min/kg and the short mean residence time of 0.5

± 0.1 hours.

The most significant active metabolite is eliminated with a plasma elimination

half-life of 2.0 ± 0.3 hours. Almost the entire dose is eliminated in the faeces.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Povidone

Lactose monohydrate

Maize starch

Croscarmellose sodium

Citric acid, anhydrous

Artificial powdered beef flavour

Silica, colloidal anhydrous

Magnesium stearate

6.2 Incompatibilities

Not applicable.

6.3 Shelf-life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years

Shelf life after first opening the immediate packaging: 100 days

Use any divided tablet at the next administration time.

6.4 Special precautions for storage

Do not store above 25°C.

Keep the bottle tightly closed in order to protect from moisture.

6.5 Nature and composition of immediate packaging

Cardboard box containing 50 or 100 tablets in a polyethylene bottle, closed with a

polypropylene child-resistant screw cap.

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6.6 Special precautions for the disposal of unused veterinary medicinal product

or waste materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such

veterinary medicinal products should be disposed of in accordance with local

requirements.

7 MARKETING AUTHORISATION HOLDER

Boehringer Ingelheim Ltd

Ellesfield Avenue

Bracknell

Berkshire

RG12 8YS

United Kingdom

8 MARKETING AUTHORISATION NUMBER(S)

VPA10007/050/001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 5

November 2012

Date of last renewal: 27

November 2015

10 DATE OF REVISION OF THE TEXT

September 2017

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